What this rule does
The federal government has registered the Therapeutic Goods (Medicines - Foreign Countries) Determination 2026 on 19 August 2026. The rule is made under the Therapeutic Goods Act 1989 and lists the foreign countries recognised for the purposes of medicines regulation in Australia.
What it replaces
This determination replaces the Therapeutic Goods (Foreign Countries) Determination 2016, which is repealed by Schedule 2 of the new instrument.
What the source does not specify
The source document does not specify which countries are listed, what has changed from the 2016 version, or when the new determination commences.
Key actions
- View the full determination at legislation.gov.au/F2026L01079 to check whether the foreign countries relevant to your business are still listed.
- Check the Explanatory Statement available on the same page at legislation.gov.au/F2026L01079 for detail on what changed from the 2016 version.
- Visit health.gov.au to find contact details for the Department of Health, Disability and Ageing if clarification is needed on product registrations or import arrangements.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.